Efficacy of Bioceramic Materials for Bone Defects Repair

NCT06249906 · tracked via the Priya Life Science China tracker

Sponsor

Nanjing First Hospital, Nanjing Medical University

Phase

Not applicable

Started

2024-02-20

Last updated

2024-03-12

Condition(s) studied

Bone LesionCartilage DegenerationOsteo Arthritis KneeBone FractureBone InjuryBone Loss

Investigational drug(s) / intervention(s)

Commercial bone implant product GroupMirco-structured Bioceramic Group

Commercial bone implant product Group: Commercial bone implant product Group with a smooth surface （without particular microstructures）.

Mirco-structured Bioceramic Group: β-tri-Calcium phosphate with microstructures such as grooves, patterns and so on.

Study summary

The purpose of this study is to demonstrate the effect of bioceramic implants on the repair of human bone defects, and to explore the application of bioceramic materials in bone defects, bone implantation, and bone fusion. The surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: 1. Patients who voluntarily take the test and sign the informed consent form; 2. Patients aged 18-65 years old with no history of allergies; 3. Patients able to communicate well with the investigator and follow the requirements of the entire trial. Exclusion Criteria: 1. Patients who refuse to sign the informed consent form to participate in the trial; 2. Patients who are not in the age range of 18 to 65 years; 3. Patients with diseases unsuitbale for the trial: history of allergies, severe cardiopulmonary disease, coagulation dysfunction, Alzheimer's disease, cerebral atrophy, acute phase or sequelae of cerebrovascular disease, cognitive impairment; 4. Patients in the acute phase of local or systemic bacterial infections; 5. Patients who cannot cooperate with the operation and evaluate the effect; 6. Other conditions that are considered inappropriate by the investigator to participate in the study.

Primary outcome measure(s)

Quality of life (SF-36) — 12 months
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used.
Level of bone healing — 12 months
X-ray, CT and MRI images would be used to evaluate the efficacy of bone healing.

Trial sites (1)

Facility	City	Region	Status
Nanjing First Hospital	Nanjing	Jiangsu	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06249906 on ClinicalTrials.gov ↗ ← All trials in China